The objective of this proposal is to establish a Statistical and Data Coordinating Center for the multicenter pacemaker Mode Selection Trial (MOST) in patients with sick sinus syndrome. The study is a two-arm, single blind, randomized clinical trial that will enroll 2,000 patients who require permanent pacemaker implantation. Qualifying patients will receive a dual chamber pacemaker, which prior to implantation, will be noninvasively programmed by random assignment to either single chamber ventricular pacing (VVIR) or dual chamber, rate-modulated pacing (DDDR). Following discharge, all patients will be followed via clinic visits at 1, 3, and 6 months, and at 6-month intervals thereafter. Patients will be recruited into the trial over a period of 3 years, with a subsequent minimum follow-up period of 1.5 years. The primary endpoint of the trial is a composite outcome consisting of all-cause mortality or nonfatal stroke. Important secondary endpoints include (1) quality of life and cost effectiveness, (2) total mortality, (3) cardiovascular mortality, (4) death, stroke, or congestive heart failure requiring hospitalization, (5) atrial fibrillation, (6) heart failure score, and (7) pacemaker syndrome. In collaboration with the Clinical Coordinating Center and the Quality of Life and Cost Center, the Data Coordinating Center will perform the following major functions: (1) participate in all phases of planning and study design; (2) coordinate the preparation of data collection forms and procedures; (3) prepare a manual of operations; (4) provide training and guidance in data collection procedures; (5) coordinate the randomization of patients; (6) efficiently organize the flow and management of all patient data; (7) establish and adhere to high standards of quality control for data management; (8) perform on-site monitoring of completed data forms; (9) prepare weekly status reports for the Clinical Coordinating Center and Quality of Life and Cost Center; (10) prepare regular reports for study committees; (11) coordinate and perform appropriate statistical analyses of study data; and (12) participate in the preparation of study publications. Noteworthy features of this proposal include: a detailed assessment of sample size requirements; telephone randomization of patients; double data entry; complete follow-up of all patients; on-site audits of data by trained nurse monitors; use of economical and efficient computer hardware and software; state-of-the-art methods of data analysis; and an experienced team of investigators. Through the services it provides, which extend across all aspects of study design, data collection, data management, and data analysis, the Data Coordinating Center will be a vital resource in the execution of this clinical trial. The results of this study are anticipated to provide important new clinical information and to greatly enhance the appropriateness of pacemaker therapy in patients with sick sinus syndrome.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01HL053973-05S1
Application #
6213483
Study Section
Special Emphasis Panel (ZHL1 (F1))
Project Start
1995-06-01
Project End
2001-05-31
Budget Start
1999-06-01
Budget End
2001-05-31
Support Year
5
Fiscal Year
2000
Total Cost
$511,100
Indirect Cost
Name
Duke University
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Holmqvist, Fredrik; Hellkamp, Anne S; Lee, Kerry L et al. (2014) Adverse effects of first-degree AV-block in patients with sinus node dysfunction: data from the mode selection trial. Pacing Clin Electrophysiol 37:1111-9
Fleischmann, Kirsten E; Orav, E John; Lamas, Gervasio A et al. (2009) Atrial fibrillation and quality of life after pacemaker implantation for sick sinus syndrome: data from the Mode Selection Trial (MOST). Am Heart J 158:78-83.e2
Fleischmann, Kirsten E; Orav, E John; Lamas, Gervasio A et al. (2006) Pacemaker implantation and quality of life in the Mode Selection Trial (MOST). Heart Rhythm 3:653-9
Lewis, Eldrin F; Hellkamp, Anne S; Pfeffer, Marc A et al. (2006) The association of the heart failure score with mortality and heart failure hospitalizations in elderly patients: insights from the Mode Selection Trial (MOST). Am Heart J 151:699-705
Hellkamp, Anne S; Lee, Kerry L; Sweeney, Michael O et al. (2006) Treatment crossovers did not affect randomized treatment comparisons in the Mode Selection Trial (MOST). J Am Coll Cardiol 47:2260-6
Sweeney, Michael O; Hellkamp, Anne S (2006) Heart failure during cardiac pacing. Circulation 113:2082-8
Shukla, Himanshu H; Hellkamp, Anne S; James, Erskine A et al. (2005) Heart failure hospitalization is more common in pacemaker patients with sinus node dysfunction and a prolonged paced QRS duration. Heart Rhythm 2:245-51
Sweeney, Michael O; Hellkamp, Anne S; Lee, Kerry L et al. (2005) Association of prolonged QRS duration with death in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation 111:2418-23
Greenspon, Arnold J; Hart, Robert G; Dawson, David et al. (2004) Predictors of stroke in patients paced for sick sinus syndrome. J Am Coll Cardiol 43:1617-22
Link, Mark S; Hellkamp, Anne S; Estes 3rd, N A Mark et al. (2004) High incidence of pacemaker syndrome in patients with sinus node dysfunction treated with ventricular-based pacing in the Mode Selection Trial (MOST). J Am Coll Cardiol 43:2066-71

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